In recent months, we have seen a growing number of non-EU medical device manufacturers reaching out with questions about the European Authorized Representative (EC REP) role. In many cases, the trigger is straightforward: access to the EU market requires an EC REP....
Over the past months, we have seen a growing number of manufacturers reaching out with questions about the Person Responsible for Regulatory Compliance (PRRC). In many cases, the initial question is straightforward: Who can act as our PRRC under MDR or IVDR? Very...
After the quieter holiday period, many organisations are now fully back at work. With that return often comes a familiar reality for medical device manufacturers: internal audits to plan and complete, and notified body audits on the horizon. This is a natural point...
Recently, the European Commission published a proposal for changes to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). This proposal reflects ongoing efforts to improve how these regulatory frameworks operate in...
This year’s Medica fair once again demonstrated why it remains one of the most influential events in the medical technology world. From visionary start-ups to seasoned industry leaders, the entire ecosystem was buzzing with new ideas, emerging technologies, and a...
Artificial Intelligence (AI) is transforming medical devices—from diagnostic algorithms to adaptive therapeutic systems. But bringing an AI-enabled medical device to market in the EU demands more than software development. You must align with the MDR (EU 2017/745),...
Bringing a medical device to the European market requires more than innovative technology — it demands meticulous documentation and clear evidence of safety and performance. Under the EU Medical Device Regulation (MDR 2017/745), your Technical File and Clinical...
In the evolving landscape of health technology, making informed decisions requires more than innovation—it demands strategic insight. Whether you’re an investor evaluating a new opportunity, a startup preparing for funding, or a procurement team assessing a new...
In the world of medical devices under EU MDR (EU 2017/745), the clinical evaluation process is a cornerstone of demonstrating safety and performance. At its heart are two interlinked documents: the Clinical Evaluation Plan (CEP) - which defines how you’ll gather...
Biological safety remains a critical part of bringing a medical device to market under EU MDR (EU 2017/745). Two documents in particular matter: the Biological Evaluation Plan (BEP), which lays the groundwork for identifying and managing biological risks; and the...
